FDA.reportPublic FDA data

Application 022030

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOVIAZFESOTERODINE FUMARATETABLET, EXTENDED RELEASE;ORAL4MGYesNo
002TOVIAZFESOTERODINE FUMARATETABLET, EXTENDED RELEASE;ORAL8MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0242Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0242Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0242Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0242Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0242Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0242Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0242Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0242Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0244Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0244Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0244Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0244Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0244Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0244Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0244Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0244Toviazfesoterodine fumaratePfizer Laboratories Div Pfizer IncNDACurrent
55154-2737Toviazfesoterodine fumarateCardinal HealthNDACurrent
55154-2737Toviazfesoterodine fumarateCardinal HealthNDACurrent
55154-2737Toviazfesoterodine fumarateCardinal HealthNDACurrent
55154-2738Toviazfesoterodine fumarateCardinal HealthNDACurrent
55154-2738Toviazfesoterodine fumarateCardinal HealthNDACurrent
55154-2738Toviazfesoterodine fumarateCardinal HealthNDACurrent
63539-183Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-183Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-183Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-183Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-183Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-183Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-183Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-183Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-242Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-242Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-242Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-242Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-242Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-242Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-242Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
63539-242Toviazfesoterodine fumarateU.S. PharmaceuticalsNDACurrent
69189-0242Toviazfesoterodine fumarateAvera McKennan HospitalNDACurrent
69189-0244Toviazfesoterodine fumarateAvera McKennan HospitalNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77676SUPPL 2024-02-29
77675SUPPL 2024-02-29
77661SUPPL 2024-02-29
77660SUPPL 2024-02-29
67876SUPPL2021-06-23
67854SUPPL2021-06-22
50428SUPPL2017-11-15
50361SUPPL2017-11-13
6726SUPPL2012-08-03
16801SUPPL2012-08-02
38109SUPPL2012-01-06
29108SUPPL2012-01-03
16799SUPPL2011-11-18
29107SUPPL2011-11-03
6725SUPPL2011-02-14
16800SUPPL2011-02-11
6724SUPPL2010-04-08
38108SUPPL2010-04-04
44668ORIG2009-02-26
42395ORIG2009-02-26
29106ORIG2008-11-07
16798ORIG2008-11-07